At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3000202 Administered as Tablet to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 3000202 as Tablet With and Without Food in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating BI 3000202 and Placebo matching BI 3000202 for Healthy. Completed, enrolled 68 participants across 1 site.
Signals
Detailed Summary
The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.
Study Details
Timeline
Arms & Interventions
SRD part: A single administration of 1 film-coated tablet identical to the active BI 3000202 treatment was orally given with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (= reference R). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). There was a minimum 3-day washout period between the two treatments.
FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (= reference R). There was a minimum 3-day washout period between the two treatments.
Interventions
BI 3000202
Placebo matching BI 3000202